Long-Term Effectiveness of Polymerized-Type I Collagen Intra-Articular Injections in Patients with Symptomatic Knee Osteoarthritis: Clinical and Radiographic Evaluation in a Cohort Study

Adrián Borja-Flores, Salvador I Macías-Hernández, Gabriela Hernández-Molina, Andric Perez-Ortiz, Eloy Reyes-Martínez, José Belzazar-Castillo de la Torre, Laura Ávila-Jiménez, María Cristina Vázquez-Bello, Marco Antonio León-Mazón, Janette Furuzawa-Carballeda, Gonzalo Torres-Villalobos, Fernanda Romero-Hernández, Cidronio Albavera-Hernández, Jesús Pérez-Correa, Hilda A Castro-Rocha, Adrián Borja-Flores, Salvador I Macías-Hernández, Gabriela Hernández-Molina, Andric Perez-Ortiz, Eloy Reyes-Martínez, José Belzazar-Castillo de la Torre, Laura Ávila-Jiménez, María Cristina Vázquez-Bello, Marco Antonio León-Mazón, Janette Furuzawa-Carballeda, Gonzalo Torres-Villalobos, Fernanda Romero-Hernández, Cidronio Albavera-Hernández, Jesús Pérez-Correa, Hilda A Castro-Rocha

Abstract

Objective: Polymerized-type I collagen (polymerized-collagen) is a downregulator of inflammation and a tissue regenerator. The aim was to evaluate the effect of intra-articular injections (IAIs) of polymerized-collagen among patients with symptomatic knee osteoarthritis (OA) in delaying or preventing joint replacement surgery. Patients and Methods. This was a cohort study of 309 patients with knee OA. Patients with mild-to-moderate disease were treated weekly with IAIs of 2 mL of polymerized-collagen for six weeks (n = 309). Follow-up was for 6-60 months. The primary endpoints included the following determinations: (1) therapeutic effect; (2) survival from total knee replacement surgery (TKR); (3) Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and pain (visual analogue scale, VAS). Clinical improvement was defined as a decrease in pain exceeding 20 mm on the VAS and the achievement of at least 20% improvement from baseline with respect to the WOMAC score. Radiographic analysis was performed at baseline and 60 months. The joint space width in the medial, lateral, and patellofemoral compartments was calculated.

Results: Patients who received IAIs of polymerized-collagen had a statistically significant improvement in the primary criteria (p < 0.05). Kaplan-Meier survival analysis of the therapeutic effect demonstrated 98.8% survival at 60 months with TKR as the endpoint. There was no significant reduction in joint space in any compartment based on the analyzed radiographs. No serious adverse events were recorded.

Conclusion: Polymerized-collagen increased the time to TKR by at least 60 months, modifying the disease course, improving functional disability, and decreasing pain.

Conflict of interest statement

The authors declare that they have no conflicts of interest.

Copyright © 2020 Adrián Borja-Flores et al.

Figures

Figure 1
Figure 1
Enrolment and Outcomes. Course of the 60-month trial. ACL: anterior cruciate ligament reconstruction; B-P-T-B: bone-patellar tendon-bone reconstruction; IAI: intra-articular injections; ITT: intention to treat; HTO: high tibial osteotomy; TKR: total knee replacement.
Figure 2
Figure 2
Covariate-adjusted relapse-free survival during the follow-up period (n = 309).
Figure 3
Figure 3
Failure function stratified by endpoint (n = 309).

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